|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | USC/Norris Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025181 |
Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: ipilimumab Biological: tyrosinase peptide Procedure: adjuvant therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | An Open-Label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma |
| Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4).
Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4, 5, 8, and 11 months in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed completely resected stage III or IV melanoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Immunologic:
If ANA positive, must be:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089 | |
| Study Chair: | Jeffrey S. Weber, MD, PhD | USC/Norris Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068934, LAC-USC-10M004, MDX-MDXCTLA4-03, NCI-4210 |
| Study First Received: | October 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00025181 History of Changes |
| Health Authority: | United States: Federal Government |
|
iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma |
recurrent intraocular melanoma stage III melanoma stage IV melanoma recurrent melanoma |
|
Neoplasms by Histologic Type Immunologic Factors Eye Neoplasms Eye Diseases Physiological Effects of Drugs Neoplasms, Nerve Tissue Adjuvants, Immunologic Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Freund's Adjuvant |